We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a ...different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants' spot sign status.
Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. Trial registration ISRCTN93732214 ( http://www.isrctn.com ).
We studied the diagnostic and prognostic value of diffusion‐ and perfusion‐weighted magnetic resonancce imaging (DWI and PWI) for the initial evaluation and follow‐up monitoring of patients with ...stroke that had ensued less than 6 hours previously. Further, we examined the role of vessel patency or occlusion and subsequent recanalization or persistent occlusion for further clinical and morphological stroke progression so as to define categories of patients and facilitate treatment decisions. Fifty‐one patients underwent stroke magnetic resonance imaging (DWI, PWI, magnetic resonance angiography, and T2‐weighted imaging) within 3.3 ± 1.29 hours, and, of those, 41 underwent follow‐up magnetic resonance imaging on day 2 and 28 on day 5. In addition, we assessed clinical scores (on the National Institutes of Health Stroke Scale, Scandinavian Stroke Scale, Barthel Index, and Modified Rankin Scale) on days 1, 2, 5, 30, and 90 and performed volumetric analysis of lesion volumes. In all, 25 patients had a proximal, 18 a distal, and 8 no vessel occlusion. Furthermore, 15 of 43 patients exhibited recanalization on day 2. Vessel occlusion was associated with a PWI‐DWI mismatch on the initial magnetic resonance imaging, vessel patency with a PWI‐DWI match (p < 0.0001). Outcome scores and lesion volumes differed significantly between patients experiencing recanalization and those who did not (all p < 0.0001). Acute DWI and PWI lesion volumes correlated poorly with acute clinical scores and only modestly with outcome scores. We have concluded on the basis of this study that early recanalization saves tissue at risk of ischemic infarction and results in significantly smaller infarcts and a significantly better clinical outcome. Patients with proximal vessel occlusions have a larger amount of tissue at risk, a lower recanalization rate, and a worse outcome. Urgent recanalization seems to be of utmost importance for these patients. Ann Neurol 2001;49:460–469
BACKGROUND AND PURPOSE—Previous systematic reviews and meta-analyses compared the efficacy and safety of patent foramen ovale (PFO) closure versus medical treatment in patients with cryptogenic ...stroke or transient ischemic attack (TIA). Recently, new evidence from randomized trials became available.
METHODS—We searched PubMed until September 24, 2017, for trials comparing PFO closure with medical treatment in patients with cryptogenic stroke/TIA using the itemsstroke or cerebrovascular accident or TIA and patent foramen ovale or paradoxical embolism and trial or study.
RESULTS—Among 851 identified articles, 5 were eligible. In 3627 patients with 3.7-year mean follow-up, there was significant difference in ischemic stroke recurrence (0.53 versus 1.1 per 100 patient-years, respectively; odds ratio OR, 0.43; 95% confidence intervals (CI), 0.21–0.90; relative risk reduction, 50.5%; absolute risk reduction, 2.11%; and number needed to treat to prevent 1 event, 46.5 for 3.7 years). There was no significant difference in TIAs (0.78 versus 0.98 per 100 patient-years, respectively; OR, 0.80; 95% CI, 0.53–1.19) and all-cause mortality (0.18 versus 0.23 per 100 patient-years, respectively; OR, 0.73; 95% CI, 0.34–1.56). New-onset atrial fibrillation occurred more frequently in the PFO closure arm (1.3 versus 0.25 per 100 patient-years, respectively; OR, 5.15; 95% CI, 2.18–12.15) and resolved in 72% of cases within 45 days, whereas rates of myocardial infarction (0.12 versus 0.09 per 100 patient-years, respectively; OR, 1.22; 95% CI, 0.25–5.91) and any serious adverse events (7.3 versus 7.3 per 100 patient-years, respectively; OR, 1.07; 95% CI, 0.92–1.25) were similar.
CONCLUSIONS—In patients with cryptogenic stroke/TIA and PFO who have their PFO closed, ischemic stroke recurrence is less frequent compared with patients receiving medical treatment. Atrial fibrillation is more frequent but mostly transient. There is no difference in TIA, all-cause mortality, or myocardial infarction.
It is well accepted that medical faculty teaching staff require an understanding of educational theory and pedagogical methods for effective medical teaching. The purpose of this study was to ...evaluate the effectiveness of a 5-day teaching education program.
An open prospective interventional study using quantitative and qualitative instruments was performed, covering all four levels of the Kirkpatrick model: Evaluation of 1) 'Reaction' on a professional and emotional level using standardized questionnaires; 2) 'Learning' applying a multiple choice test; 3) 'Behavior' by self-, peer-, and expert assessment of teaching sessions with semistructured interviews; and 4) 'Results' from student evaluations.
Our data indicate the success of the educational intervention at all observed levels. 1) Reaction: The participants showed a high acceptance of the instructional content. 2) Learning: There was a significant increase in knowledge (P<0.001) as deduced from a pre-post multiple-choice questionnaire, which was retained at 6 months (P<0.001). 3) Behavior: Peer-, self-, and expert-assessment indicated a transfer of learning into teaching performance. Semistructured interviews reflected a higher level of professionalism in medical teaching by the participants. 4) Results: Teaching performance ratings improved in students' evaluations.
Our results demonstrate the success of a 5-day education program in embedding knowledge and skills to improve performance of medical educators. This multimethodological approach, using both qualitative and quantitative measures, may serve as a model to evaluate effectiveness of comparable interventions in other settings.
Secondary expansion of hematoma after spontaneous intracerebral hemorrhage occurs frequently and early with the potential sequelae of functional deterioration or death. The aim of this topical review ...is to give a summary of current evidence- and experience-based options to avoid or attenuate hematoma expansion.
We reviewed the literature of the past 10 years on efforts to restrict spontaneous intracerebral hemorrhage expansion by searching Medline and adding related articles known to us. Based on evidence, current guidelines, and our own clinical practice, we have collected consistent and inconsistent pieces of data. These were differentiated according to surgical versus medical approaches, weighed and discussed with regard to expectable benefit, potential risk, and practicability. Finally, we have outlined promising future approaches.
Although consistent evidence on the topic is generally limited, some important studies have provided data on risk factors predicting spontaneous intracerebral hemorrhage expansion implying ways of directing therapy toward these risk factors. Large trials have shed light on 4 major efforts to avoid hematoma expansion: surgical hematoma treatment, reduction of hypertension, reversal of coagulopathies or anticoagulants, and hemostatic therapy. The results were largely disappointing but provide insights for new trials. Future strategies include the combination of surgical and medical treatment and the use of neuroprotectants.
Early restriction of intracerebral hemorrhage is of paramount importance because secondary volume expansion leads to outcome deterioration and death. Although there appear to be few indications for neurosurgical measures, nonsurgical measures such as reduction of hypertension and normalization of altered coagulation seem to be beneficial. However, the routine use of coagulation factors outside of warfarin-associated spontaneous intracerebral hemorrhage cannot generally be recommended at present. The same applies for future approaches such as combined medical-surgical approaches and neuroprotective therapies at this point.
In this randomized trial involving patients with intracerebral hemorrhage, intensive reduction in systolic blood pressure to a target of 110 to 139 mm Hg did not result in a lower rate of death or ...disability than standard reduction to a target of 140 to 179 mm Hg.
An acute hypertensive response in patients with intracerebral hemorrhage is common
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and may be associated with hematoma expansion and increased mortality.
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The second Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial
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(INTERACT2) included patients with spontaneous intracerebral hemorrhage who had a systolic blood pressure of 150 to 220 mm Hg within 6 hours after symptom onset. The rate of death or disability among patients randomly assigned to intensive reduction in the systolic blood-pressure level, with a target systolic blood pressure of less than 140 mm Hg within 1 hour, was nonsignificantly lower than the rate among those . . .
The value of neurosurgical interventions after spontaneous intracerebral hemorrhage (SICH) is uncertain. We evaluated clinical outcomes in patients diagnosed with SICH within 3 hours of symptom onset ...who underwent hematoma evacuation or external ventricular drainage (EVD) of the hematoma in the Factor Seven for Acute Hemorrhagic Stroke Trial (FAST). FAST was a randomized, multicenter, double-blind, placebo-controlled trial conducted between May 2005 and February 2007 at 122 sites in 22 countries. Neurosurgical procedures (hematoma evacuation and external ventricular drainage) performed at any point after hospital admission were prospectively recorded. Clinical outcomes evaluated were post-SICH disability, as assessed by the modified Rankin Scale; neurologic impairment, as assessed by the National Institutes of Health Stroke Scale; and mortality at 90 days after SICH onset. The impact of neurosurgical procedures on clinical outcomes was evaluated using multivariate logistic regression analysis, controlling for relevant baseline characteristics. Fifty-five of 821 patients underwent neurosurgery. Patients who underwent hematoma evacuation or EVD were on average younger, had greater baseline neurologic impairment, and lower levels of consciousness compared with patients who did not undergo neurosurgery. After adjusting for these differences and other relevant baseline characteristics, we found that neurosurgery was generally associated with unfavorable outcomes at day 90. Among the patients who underwent hematoma evacuation, those with lobar ICH had less ICH expansion than those with deep gray matter ICH, and the smaller expansion was associated with lower mortality. ICH volume was substantially decreased in patients who underwent hematoma evacuation between 24 and 72 hours after hospital admission, and this was associated with better clinical outcome. In conclusion, a small number of patients who underwent neurosurgery in FAST exhibited no overall clinical benefit from neurosurgical intervention, although outcomes varied by type of surgery, time of surgery, and hematoma location. Our findings support the need for further research into the value of neurosurgery in patients with SICH.
Idarucizumab was 100% effective in reversing the anticoagulant effect of dabigatran among 300 patients with uncontrolled bleeding (median time to bleeding cessation, 2.5 hours) and among 200 patients ...who required an urgent procedure (median time to procedure initiation, 1.6 hours).
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